TY - JOUR
T1 - Danish very-low-dose aspirin after carotid endarterectomy trial
AU - Boysen, G
AU - Sørensen, P S
AU - Juhler, M
AU - Andersen, A R
AU - Boas, J
AU - Olsen, J S
AU - Joensen, P
PY - 1988/10
Y1 - 1988/10
N2 - The effect of very-low-dose aspirin as an antithrombotic agent was evaluated blindly in 301 patients who had recently undergone carotid endarterectomy. After randomization, 150 patients received aspirin and 151 received placebo. The two groups were comparable with regard to age, sex, blood pressure, previous cerebrovascular events, and smoking habits. The effect of the study medication on platelet aggregation was measured twice in each patient during the first 2 months and at each follow-up visit; the dose was individually adjusted. In 76% of the patients receiving aspirin, 50 mg/day gave satisfactory platelet inhibition, 13% needed 60 mg/day, 8% needed 70 mg/day, and 3% needed 100 mg/day. Platelet aggregation was found to be inhibited in only 1.2% of the measurements in the patients receiving placebo. Observation during treatment averaged 21 months; total intention-to-treat follow-up averaged 25 months. For the combined outcome events of transient ischemic attack, stroke, acute myocardial infarction, and vascular death, aspirin reduced risk by 11% (95% confidence limits: -38% to 48%, p greater than 0.1). Thus, there was no significant effect of very-low-dose aspirin in our trial.
AB - The effect of very-low-dose aspirin as an antithrombotic agent was evaluated blindly in 301 patients who had recently undergone carotid endarterectomy. After randomization, 150 patients received aspirin and 151 received placebo. The two groups were comparable with regard to age, sex, blood pressure, previous cerebrovascular events, and smoking habits. The effect of the study medication on platelet aggregation was measured twice in each patient during the first 2 months and at each follow-up visit; the dose was individually adjusted. In 76% of the patients receiving aspirin, 50 mg/day gave satisfactory platelet inhibition, 13% needed 60 mg/day, 8% needed 70 mg/day, and 3% needed 100 mg/day. Platelet aggregation was found to be inhibited in only 1.2% of the measurements in the patients receiving placebo. Observation during treatment averaged 21 months; total intention-to-treat follow-up averaged 25 months. For the combined outcome events of transient ischemic attack, stroke, acute myocardial infarction, and vascular death, aspirin reduced risk by 11% (95% confidence limits: -38% to 48%, p greater than 0.1). Thus, there was no significant effect of very-low-dose aspirin in our trial.
KW - Aspirin/administration & dosage
KW - Carotid Arteries/surgery
KW - Clinical Trials as Topic
KW - Endarterectomy
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Placebos
KW - Platelet Aggregation/drug effects
KW - Random Allocation
KW - Thrombosis/prevention & control
U2 - 10.1161/01.str.19.10.1211
DO - 10.1161/01.str.19.10.1211
M3 - Journal article
C2 - 3051530
SN - 0039-2499
VL - 19
SP - 1211
EP - 1215
JO - Stroke
JF - Stroke
IS - 10
ER -